Process and operations strategies to enable global access to antibody therapies

Kelley Brian; Renshaw Todd; Kamarck Michael

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Process and operations strategies to enable global access to antibody therapies

机译：过程和运营策略，以实现全球对抗体治疗的进入

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Few monoclonal antibodies are currently approved for treating infectious diseases, but multiple products are in development against a broad range of infectious diseases, including Ebola, influenza, hepatitis B, HIV, dengue, and COVID-19. The maturity of mAb technologies now allow us to identify and advance neutralizing mAb products to the clinic at "pandemic pace", as the pipeline of mAbs targeting SARS-CoV-2 has demonstrated. Ensuring global access to these products for passive immunization, however, will require both low manufacturing cost and multi-ton production capacity-particularly for those infectious diseases where the geographic burden falls mostly in low- and middle-income countries or those with pandemic potential. Analysis of process economics and manufacturing technologies for antibody and other parenteral protein therapeutics demonstrates the importance of economies of scale to reducing the cost of goods for drug substance manufacturing. There are major benefits to convergence on a standardized platform process for antibody production that is portable to most existing very large-scale facilities, carries low risk for complications during process transfer and scale-up, and has a predictable timeline and probability of technical and regulatory success. In the case of an infectious disease with pandemic potential which could be treated with an antibody, such as COVID-19 or influenza, these advantages are paramount.

机译：目前批准了几种单克隆抗体用于治疗传染病，但多种产品正在开发出广泛的传染病，包括埃博拉，流感，乙型肝炎，艾滋病毒，登革热和Covid-19。 MAB技术的成熟现已允许我们以“大流行速度”识别和提前中和MAB产品，因为靶向SARS-COV-2的MAB管道。然而，确保全球对被动免疫产品的进入，需要低制造成本和多吨的生产能力 - 特别是对于那些地理负担主要在低收入和中等收入国家或具有大流行潜力的人的传染病。对抗体和其他肠胃外蛋白质治疗方法的过程经济学和制造技术的分析表明了规模经济的重要性降低了降低药物制造商品的成本。在标准化平台过程中收敛有重大好处，用于抗体生产，该过程可用于大多数现有的大规模设施，在流程转移和扩大过程中的并发症风险低，具有可预测的时间表和技术和监管的可能性成功。在具有大流行潜力的传染病的情况下，可以用抗体处理，例如Covid-19或流感，这些优点是至关重要的。

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《Biotechnology Progress》 |2021年第3期|共15页
作者
Kelley Brian; Renshaw Todd; Kamarck Michael;
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Vir Biotechnol San Francisco CA 94158 USA;

Vir Biotechnol San Francisco CA 94158 USA;

Vir Biotechnol San Francisco CA 94158 USA;

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原文格式 PDF
正文语种 eng
中图分类生物科学;
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antibody manufacturing; operations strategy; pandemic response; process economics;

机译：抗体制造;操作策略;大流行反应;过程经济学;

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10. Decision-making is the process of analyzing information about a problem situation and comparing it to a specific conclusion in order to solve a specific problematic (Yıkılmaz, 2001; Miller and Byrnes, 2001). Decision-making styles are a mechanism that is influenced by the internal and external conditions that determine the direction of the decisions of the individual, the content of the decision-making process, and the outcome of the decision-making process (Payne, Bettman and Johson, 1993; Bavol’ár and Orosová, 2015). ACT is a contemporary member of the Cognitive Behavioral Therapy family. ACT (Acceptance and commitment therapy) has both similar and different directions with Behavioral Therapies and Cognitive Therapies (Herbet and Forman, 2011; Hayes, 2004). KKT responds to classical behavioral treatments using both existential and cognitive approaches in the analysis of behavior. KKT is a science wing that tries to solve human problems with a wider perspective aimed at solving problematic human behaviors (Plumb, Stewart, Dahl and Lundgren, 2009). It is seen that there is very little research about the new approach of ACT approach when the aiming country of our country is screened and it is thought that our country will contribute to the field of psychological counseling with the work done. In the scope of the research, experimental and control groups and preliminary test, post-test and follow-up measurements of 2x3 experimental design were used. The study's study group consists of a total of 24 (12 experimental and 12 control groups) university students studying in different departments and levels, continuing their education in the academic year of 2015-2016 in Ağrı province and İbrahim Chechen University in 2015-2016 academic year. The average age of participants in the experiment and control group is 20. There were 12 participants in the experimental group, 7 female and 5 male, and 12 participants, 7 female and 5 male in the control group. Personal Information Form and Decision Making Style Scale prepared by the researcher were used in the research. In order to decide on the tests to be used in the course of analyzing the data, the scores of the participant's Decision Styles Scale pre-test, which are placed primarily in the experimental and control groups, it was analyzed whether the basic expectations of parametric tests were answered. As a result of the analysis made, the scores, skewness and kurtosis coefficients obtained from the Decision Making Styles Scale were given to the experimental and control groups. It was determined that the distribution was normal in the result of Shapiro-Wilk test, in which the skewness and kurtosis coefficients of each sub-scale were ranked between -1 and +1. Participants in the experimental and control groups; homogeneity test results for decision-style pre-test measurements indicate that the data are homogeneous. According to the results of the Mauchly Globalness Test, it has been determined that working supports the hypothesis. It was determined that there was no significant difference between the pre-test scores obtained from dependent decision-making style of experiment and control groups, but the test group showed lower mean scores at the significant level within the scores of post-test and follow-up tests. Therefore, it can be said that the ACT-oriented psychoeducation program applied to the experimental group reduces the dependent decision-making style scores from the decision style sub-dimensions and the psychoeducation program has a lasting effect. It was determined that there was no significant difference between pre-test, post-test and follow-up scores obtained from the Spontaneous-Instant Decision Style of experiment and control groups. Thus, it can be said that this situation does not cause a significant difference in the Spontaneous-Decision-Making Style scores from the decision style sub-dimensions of the ACT-oriented psychoeducation program applied to the experimental group. The ACT -oriented psychoeducation program had a decline in the intuitive decision-making styles of the individuals, but this decrease did not create significant differences. Thus, it can be said that this situation does not make a meaningful difference in the intuitive decision style scores from the decision style sub-dimensions of the KKT oriented psychoeducation program applied to the experimental group. 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Process and operations strategies to enable global access to antibody therapies

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